Blog
Medicinal products advertisement – what is it and what requirements must it fulfill?
02 August 2023
Nowadays it is difficult to imagine an economic entity functioning without using any form of advertisement. What about medicinal products? Do life-saving and life-enhancing products also need advertising? Do medicines which have pervaded our daily lives need to be additionally advertised? On the other hand, how do we know whether to choose company A’s medicine or company […]
Is market analysis important for pharmaceutical project success?
20 July 2023
Big pharma has the unlimited budgets, but is it true? In 2012 the medical and patient world held its breath because of Sanofi’s new product launch – Zaltrap (afibercept), a medicinal product registered for the treatment of colon cancer and its price of 9600 $/month. The price of Avastin (bevacizumab), its closest competitor, was half […]
How to increase the safety of used cosmetics? A few words about cosmetovigilance
12 July 2023
Every day, a lot of people experience side effects after using cosmetics, but not everyone knows that they can report them to the responsible authorities. Why reporting adverse reactions is important and how it affects the safety of cosmetics? If you want to find out what cosmetovigilance is – we invite you to read the […]
IMPD for ATMP – going into clinic
12 May 2023
In recent years, a new class of medical products, named Advanced Therapy Medicinal Products (ATMPs), consisting of cellular or genetic components has quickly moved from Research and Development labs to clinics, mostly as products under evaluation in clinical trials. These new therapeutic options already have and surely will revolutionize the treatment of many previously incurable […]
Safety management of adverse reactions from clinical trials – what you need to know
13 April 2023
Safety management is key to any clinical trial and an utmost obligation to any pharmaceutical company introducing new medicinal products to the market. Whilst conducting a clinical trial, safety of all subjects is paramount, therefore best efforts should be made to capture any safety issues. All safety aspects have to be analyzed in the study […]
Responsibilities of the Marketing Authorisation Holder (MAH) after obtaining the Marketing Authorisation (MA) for the medicinal product in Poland
01 March 2023
As soon as the MA has been granted for the medicinal product, the MAH is responsible for the product’s quality, efficacy and safety. Therefore, the MAH is obliged to comply with national and European legislation. It is important to remember that depending on the country in which the medicinal product has obtained the MA, the […]
Clinical trials – where to conduct them?
01 February 2023
Each drug developer at some point reaches the moment when it is necessary to run a clinical trial, and has to ask themselves where to test the developed medicinal product. However, there is no easy and straightforward answer as there are no formal limits in choosing the country. In this article we would like to […]
Skin products – What’s new in the ICH Q3D Guideline For Elemental Impurities?
18 January 2023
Have you heard about the new version of the ICH Q3D Guideline for Elemental Impurities? Do you know, it was adopted on 24 March 2022 by The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency’s (EMA), published on 2 May 2022 and came into force on 24 September 2022. The […]
Pharmacovigilance system provider
06 December 2022
Pharmacovigilance (PV) is the science and activities related to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. It is essential to monitor post-authorisation safety of medicines to gather all safety data from a large number of various patients with numerous conditions and concomitant therapies using the drug for a […]
TOP 10 challenges in Market Access of ATMPs
25 November 2022
The Market Access (MA) topic is fascinating in itself, but like any topic, it will be more easily remembered and assimilated if it is described in a non-standard way. Instead of using official definitions regarding Market Access, let’s go through the subject of MA on the example of Advanced Therapy Medicinal Products (ATMPs). Quite challenging? Probably […]
Unstoppable changes in pharmacovigilance of veterinary medicinal products
04 November 2022
Are you ready for the new regulations? At the beginning of year 2022 Veterinary Regulation 2019/06 has come into force, introducing innovative approach to safety surveillance of veterinary medicinal products. Marketing Authorisation Holders (MAHs) will now face new challenges with regard to fulfilling legal obligations and maintaining their pharmacovigilance system up-to-date. Below provided summary gives […]
What is EudraVigilance?
31 August 2022
EudraVigilance: basic information EudraVigilance (European Union Drug Regulating Authorities Pharmacovigilance) is a system designed for reporting suspected adverse reactions to medicines, otherwise known as adverse drug reactions (ADRs). It has been in operation since December 2001. The European Medicines Agency (EMA) is responsible for developing, maintaining and coordinating the database. EudraVigilance supports the safe and […]